- Federal Register Notice announcing the Proposed Rule
- Docket Folder FDA-2021-N-0471 provides full text of the Rule
- Public Meetings to Discuss Proposed Changes
(February 14 and 25, 2022)
The FDA is proposing a revision to Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule that would change the pre-harvest agricultural water requirements for covered produce (other than sprouts). The requirements in this proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule with requirements for systems-based pre-harvest agricultural water assessments. These assessments would be used to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces, and to determine whether corrective or mitigation measures are needed to minimize the risks associated with pre-harvest agricultural water.
These proposed requirements are intended to address stakeholder concerns about the complexity and practical implementation of certain pre-harvest agricultural water requirements in the Produce Safety Rule while continuing to protect public health. The requirements also are designed to be adaptable to future advancements in agricultural water quality science.
We are not proposing to change the requirements for harvest and post-harvest uses of agricultural water, or the agricultural water requirements for sprouts. Sprouts are subject to specific pre-harvest agricultural water requirements, and the compliance dates for those sprouts requirements have passed.
1. Agricultural Water Assessment
The proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule for covered produce (other than sprouts) with requirements for systems-based pre-harvest agricultural water assessments to be used for hazard identification and risk management decision-making (see the webpage for the final Produce Safety Rule for a description of the requirements as currently written). Under the proposed requirements, covered farms would be required to conduct pre-harvest agricultural water assessments once annually, and whenever a change occurs that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces. As part of their pre-harvest agricultural water assessments, these farms would be required to evaluate certain factors (listed below) that could impact produce safety.
Factors that Covered Farms would be Required to Assess as Part of an Agricultural Water Assessment, If the Proposed Rule is Finalized
|Agricultural water system(s)||
|Agricultural water practices||
|Other relevant factors||
If finalized as proposed, covered farms may need to implement corrective or mitigation measures based on the outcomes of their pre-harvest agricultural water assessments. This could include expedited mitigation measures to address known or reasonably foreseeable hazards in agricultural water systems associated with animal activity, biological soil amendments of animal origin (BSAAOs), or untreated or improperly treated human waste on adjacent and nearby land. The following chart summarizes the proposed requirements for actions taken following the agricultural water assessment determinations:
|If you determine||Then you must|
that your agricultural water is not safe or is not of adequate sanitary quality for intended use(s)
|there is one or more known or reasonably foreseeable hazards related to animal activity, BSAAOs, or untreated or improperly treated human waste for which mitigation is reasonably necessary||
|there is one or more known or reasonably foreseeable hazards not related to animal activity, BSAAOs, or untreated or improperly treated human waste, for which mitigation is reasonably necessary||
|that there are no known or reasonably foreseeable hazards for which mitigation is reasonably necessary||
3. Required management review of Pre-harvest Agricultural Water Assessments
The proposed rule also includes a requirement for supervisory review of the written pre-harvest agricultural water assessment and the determinations that were made about corrective or mitigation measures based on the outcomes of the assessment.
The proposed rule exempts covered farms from conducting a pre-harvest agricultural water assessment if they can demonstrate that their pre-harvest agricultural water for covered produce (other than sprouts):
- meets certain requirements that apply for harvest and post-harvest agricultural water (such as the microbial quality criterion and testing requirements for untreated ground water);
- is received from a public water system or supply that meets requirements established in the rule (provided that the farm has public water system results or certificates of compliance demonstrating that the water meets relevant requirements); or
- is treated in accordance with the standards outlined in the Produce Safety Rule.
In light of stakeholder concerns about complexity, we are proposing to reorganize subpart E to more clearly delineate which provisions apply based on how the water is used. This means that some requirements may be renumbered. However, FDA is not proposing to alter the requirements in subpart E for sprouts; for water used during harvest, packing and holding activities; or for treatment of agricultural water. In addition, the proposed rule contains definitions for “agricultural water assessment” and “agricultural water system” to provide additional clarity.
In July 2022, the FDA issued a supplemental notice of proposed rulemaking (SNPRM) to the agricultural water proposed rule to extend the compliance dates for the proposed pre-harvest agricultural water provisions. The SNPRM proposes to establish the following compliance dates for the pre-harvest agricultural water requirements for covered produce other than sprouts:
- 2 years and 9 months after the effective date of a final rule for very small businesses;
- 1 year and 9 months after the effective date of a final rule for small businesses; and
- 9 months after the effective date of a final rule for all other businesses.
The SNPRM also clarifies that we intend to continue enforcement discretion for the harvest and post-harvest agricultural water requirements of the Produce Safety regulation until the following dates:
- January 26, 2025, for very small businesses;
- January 26, 2024, for small businesses; and
- January 26, 2023, for all other businesses.
As has been done with other FSMA rules, the FDA plans to take an “educate before and while we regulate” posture as we begin implementing the harvest and post-harvest requirements. For the first year of compliance, the FDA intends to work closely with state and industry partners to advance training, technical assistance, educational visits and on-farm readiness reviews to prepare both growers and state regulators for implementing these provisions prior to initiating routine inspections verifying compliance. The FDA will provide further communications as additional resources become available.
The proposed rule is available for public comment for 120 days. Comments should be submitted to docket FDA-2021-N-0471 on Regulations.gov.
The FDA encourages comments and questions to be submitted to the docket so that the agency can fully consider all feedback.
Additional questions, and requests for meeting and speaker engagements can be submitted via the forms below. For meeting and speaking requests, please include a completed request form when you contact us.
- FSMA Final Rule on Produce Safety
- Constituent Update: FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements (2022)
- Constituent Update: FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule (2021)
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Proposed Rule) Preliminary Regulatory Impact Analysis
- Federal Register Notice: Extension of Compliance Dates for Subpart E of the Final Rule on Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (2019)
- Constituent Update: FDA Finalizes New Compliance Dates for Agricultural Water Requirements (2019)
- Announcement: FDA Considering Simplifying Agricultural Water Standards (2017)